AI Diabetes Tech Continues FDA's Software Push

A cloud-based, artificial intelligence (AI)-driven software program designed to aid decision making for diabetes has received the green light from the FDA, marking yet another tech-centric step forward for the regulator.

DreaMed Diabetes got the OK to market its DreaMed Advisor Pro solution yesterday, opening the door to high-tech decision support for clinicians who treat patients with type 1 diabetes. The software is designed for patients who use insulin pumps and continuous glucose monitoring, according to an announcement from the company.

“This is an innovation that can improve people’s lives, and the FDA decision confirms what we believe is an important step in making a more meaningful connection between the healthcare provider and their type 1 diabetes patients,” DreaMed CEO Eran Atlas, MBA, MS, said in a statement.

More than 1 million patients in the US have type 1 diabetes, and roughly half of all patients in the country’s largest clinical registry use insulin pumps, according to DreaMed. All individuals who use an insulin pump to manage their type 1 diabetes could conceivably use this software.

The FDA marketing approval of DreaMed Advisor Pro follows a larger trend within both the regulator’s walls and the broader healthcare industry. As medical software continues its rise to clinical prominence, developers for tech start-ups and legacy healthcare companies have worked to produce digital health solutions—and to carve out their spot in a lucrative market.

But there exists—or, perhaps, existed—a disconnect between the nature of the FDA and that of cutting-edge, Silicon Valley-style software developers. The big problem: Regulators move slowly, and tech companies move at breakneck speed.

The FDA, however, recognized this chasm and moved to bridge it. Last year, the agency announced the launch of a precertification pilot program, with the goal of approving and bringing potentially life-saving software to market more quickly. Major names like Johnson & Johnson, Apple, and Fitbit signed on as participants, alongside hungry health-tech newcomers. In April, the FDA said it had begun preparing to release the resultant model.

During the same period, the regulator had approved a number of medical software products to enter the market. AI-powered software programs for stroke triage, wrist fracture detection, and diabetic retinopathy are among the approvals that have taken place in just the past few months. DreaMed Advisor Pro, of course, continues this budding tradition.

Earlier this year, its manufacturer also secured an approval to market the software in the European Union, where a similar tech-focused movement has taken hold of healthcare.

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